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The purpose of this study is to determine the safety and efficacy of SL-701 as a treatment for recurrent glioblastoma multiform (GBM).
This is a multicenter, open-label Phase 1/2 study evaluating the efficacy and safety of SL-701 as a treatment for recurrent GBM, divided into 2 stages. Seventy-four (74) participants were treated in the study, 46 in Stage 1 and 28 in Stage 2, men and women at least 18 years of age, all of whom showed unequivocal evidence of either a first tumor recurrence or progression during or following an initial treatment regimen before enrollment in this study. At least 54 of the 74 treated participants had measurable disease based on contrast-enhanced magnetic resonance imaging or computed tomography scans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SL-701 + GM-CSF + Imiquimod | Experimental | Participants will receive SL-701 with the vaccine adjuvants granulocyte macrophage-colony stimulating factor (GM-CSF) injection and imiquimod topical cream. A complete dose of study drug consists of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site is repeated at 24 hours after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) will be administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes of SL-701 emulsion injection) to the SL-701 emulsion injection site. In addition to the SL-701 emulsion injection, the participant will receive a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion. An additional dose of imiquimod cream will be applied at the same site by the participant 24 hours later. |
|
| SL-701; poly-ICLC 1.6 mg; bevacizumab | Experimental | SL-701 emulsion and the adjuvant poly-ICLC will be administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab will be administered every 2 weeks, subsequent to the administration of SL-701/poly-ICLC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose) | Drug | 1.0 mL injection taken from 0.7 mL of SL-701 mixed at a 1:1 (v/v) ratio with 0.7 mL of Montanide. Preferred site of SC injection is in the right or left upper arms. Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC should be administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Regimen-limiting Toxicity (RLT) | RLT included any events that occurred anytime through the first 12 doses of study treatment that were considered possibly, probably, or definitely related to investigational therapy and ranged from Grade ≥3 bronchospasm or Grade 2 bronchospasm that did not resolve within 24 hours despite appropriate medical treatment to cerebral edema associated with severe clinical manifestations (Grade 4) that were considered related to study therapy by the investigator. | Approximately 24 weeks |
| Number of Participants Experiencing Sudden or Unexpected Death Related to SL-701 or SL-701 in Combination With Bevacizumab | A safety review occurred following each sudden or unexpected death that was not considered by the investigator to be a disease-related mortality and was considered to be related to SL-701. | Day 1 through Month 12 |
| Overall Survival at 12 Months (OS-12) | OS-12 was defined as the number of participants surviving at 12 months after the first injection of SL-701 and was calculated using the Clopper-Pearson Method. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was the percentage of participants who had at least 1 overall tumor response of complete response (CR) or partial response (PR) documented on 2 consecutive magnetic resonance images (MRIs) ≥4 weeks apart by modified response assessment in neuro-oncology (RANO) criteria. | 3 years |
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Inclusion Criteria:
18 years of age or older.
Histologically confirmed GBM or World Health Organization (WHO) Grade IV variants (gliosarcoma, glioblastoma with oligodendroglial features, or giant cell glioblastoma).
Unequivocal evidence of a first tumor recurrence or progression on the initial treatment regimen (prior to enrollment on this study), consisting of surgical intervention (biopsy and/or resection), radiation, and temozolomide chemotherapy, as assessed by MRI or CT scan of the brain with or without contrast within 14 days prior to the start of SL-701. If receiving corticosteroids, the dose must be stable or decreasing for at least 5 days prior to the scan. Participants unable to undergo MRI because of non-compatible devices can be enrolled, provided CT scans are obtained and are of sufficient quality. For each participant, the same imaging technique should be performed throughout the study, for purposes of assessing tumor response or PD.
For participants who have undergone resection of recurrent or progressive tumor prior to study enrollment, the following conditions must apply:
Recovery from the effects of surgery.
Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, an MRI should be performed:
Participants who have not had resection of recurrent or progressive disease must have measurable disease.
At least 56 of the approximately 76 participants treated must have measurable disease, defined as at least one, contrast-enhancing lesion measuring at least 1 cm in 2 planes (axial, coronal, or sagittal).
No evidence of hemorrhage on the baseline MRI or CT scan other than those that are Grade ≤ 1 and either post-operative or stable on at least two consecutive scans.
Recovery from prior therapy toxicity, defined as resolution of all treatment-related adverse events (AEs) to Grade ≤ 1 or pre-treatment baseline (except alopecia and lymphopenia).
At least 12 weeks from prior radiotherapy to the start of SL-701 unless there is new enhancement outside of the radiation field or unequivocal histopathologic evidence of recurrent tumor subsequent to radiotherapy.
No chemotherapy or investigational agent for at least 3 weeks prior to the start of SL-701.
Human leukocyte antigen (HLA)-A2 positive.
A tumor tissue sample is provided for immunohistochemical analysis of relevant antigens, immune markers and potential prognostic factors. Preferably a paraffin block or 10-12 unstained slides will be submitted prior to study entry. Participants for whom tumor samples are unavailable or inadequate are permitted to participate in the study; however, the absence of available/adequate tumor specimen must be documented.
Karnofsky performance status (KPS) score ≥ 70%.
Adequate organ function, including the following:
Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to the start of SL-701 treatment.
Female participants of childbearing potential and sexually active male participants must agree to use an acceptable form of contraception for heterosexual activity (that is, oral contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for > 40 days before Screening, during the study, and for 60 days after the last dose of study drug. Men should not donate semen during the study and for 60 days after the last dose of study drug.
Female participants without childbearing potential (spontaneous amenorrhea for > 12 months or surgically sterilized by tubal ligation, hysterectomy, or bilateral oophorectomy > 6 months before Screening) are eligible for inclusion without contraceptive use restriction.
Able and willing to comply with protocol requirements, in the opinion of the investigator.
A written and voluntarily signed informed consent must be obtained from the participant or legally authorized representative, in accordance with local regulations, before the initiation of any study related procedures. The participant or legally authorized representative must be able to read and understand the informed consent form (ICF).
Exclusion Criteria:
Prior cancer chemotherapy, bevacizumab (or other vascular endothelial growth factor [VEGF]/VEGF receptor [VEGFR]-directed agent), or an investigational agent for recurrent/progressive GBM or prior bevacizumab as part of initial therapy (prior chemotherapy or investigational agents are permitted as part of initial therapy; VEGF/VEGFR-directed agents are not permitted).
Contrast-enhancing tumor that is any of the following:
Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or equivalent or requirement of increasing dose of systemic corticosteroids during the 7 days prior to the start of SL-701 treatment.
Surgical resection or major surgical procedure within 4 weeks prior to the start of SL-701, or stereotactic biopsy within 7 days prior to the start of SL-701.
Radiation therapy, local therapy (except for surgical re-resection), or systemic therapy following first recurrence/progressive disease. Excluded local therapies include stereotactic radiation boost, implantation of carmustine biodegradable wafers (Gliadel), intratumoral or convection-enhanced delivery administered agents, etc.
Active infection requiring intravenous antibiotics.
History of cancer (other than GBM) within the past 2 years that has metastatic or local recurrence potential and could negatively impact survival and/or potentially confound tumor response assessments within this study.
Clinically significant cardiovascular disease (for example, uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction or stroke within 6 months of study entry, uncontrolled hypertension or clinically significant arrhythmias not controlled by medication).
Known immunosuppressive disease or active systemic autoimmune disease such as systemic lupus erythematosus, human immunodeficiency virus infection, Hepatitis B, or Hepatitis C, or has taken an immunosuppressive agent within 4 weeks prior to the start of SL-701 treatment. Participants with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Any condition which in the investigator's opinion makes the participant unsuitable for study participation.
Requires therapeutic anticoagulation with warfarin at baseline; participants must be off warfarin or warfarin-derivative anti-coagulants for at least 7 days prior to starting study drug; however, therapeutic or prophylactic therapy with low-molecular weight heparin is allowed.
Has history of known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhage within 12 months of start of study drug.
Has evidence of intratumoral or peritumoral hemorrhage on baseline MRI scan other than those that are ≤Grade 1 and either post-operative or stable on at least 2 consecutive MRI scans
Has gastrointestinal bleeding or any other hemorrhage/bleeding event National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) >Grade 3 within 6 months of start of study drug.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Barrow Neurological Institute |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | SL-701 + GM-CSF + Imiquimod | Participants received SL-701 with the vaccine adjuvants granulocyte-macrophage colony-stimulating factor (GM-CSF) injection and imiquimod topical cream. A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion subcutaneous (SC) injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 hours (h) after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site. In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 micrograms (μg) close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2015 | Oct 14, 2024 |
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|
|
| Bevacizumab | Drug | Following the administration of SL-701 and poly-ICLC, bevacizumab will be administered IV at a dose of 10 mg/kg. Bevacizumab infusions may occur over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
|
| SL-701 + GM-CSF | Drug | 1.0 mL injection taken from 0.7 mL of SL-701 mixed at a 1:1 (v/v) ratio with 0.7 mL of Montanide. Preferred site of SC injection is in the right or left upper arms. 150 μg GM-CSF should be administered as a SC injection immediately after SL-701 emulsion administration and within 1 cm from the center of the SL-701 emulsion injection site. |
|
| Imiquimod | Drug | Within 5 minutes following the administration of the SL-701 emulsion, approximately 125 mg of imiquimod cream will be applied topically on the injection site. The imiquimod cream should be rubbed in until the cream is no longer visible. |
|
| Disease Control Rate (DCR) |
DCR was the percentage of participants whose best response was either CR, PR, or stable disease (SD) documented on 2 consecutive MRIs ≥4 weeks apart by modified RANO criteria. |
| 3 years |
| Duration of Response (DoR) | DoR was defined as the time from the date measurement criteria were first met for objective response (either CR or PR) until the first date that the criteria for progressive disease (PD) was met, or death due to any cause, whichever occurred first, by modified RANO. If a participant did not progress or die after a response of CR or PR, then the participant's DoR was censored at the date of the participant's last tumor assessment. Only participants who attained a confirmed response of either CR or PR were included in the estimation of DoR (calculated using the Kaplan-Meier method). | 3 years |
| Duration of Disease Control (DDC) | DDC was defined as the time from the date measurement criteria were first met for objective response (either CR, PR, or SD) until the first date that the criteria for PD were met, or death due to any cause, whichever occurs first, by modified RANO. If a participant did not progress or die after a response of CR, PR or SD, then the participant's DDC was censored at the date of the participant's last tumor assessment. Only participants who attained a confirmed response of either CR, PR or SD were included in the estimation of DDC. | 3 years |
| Progression-free Survival at 6 Months (PFS-6) | PFS-6 was defined as the time from the date of the first injection of SL-701 to the date of disease progression or death from any cause, whichever occurred first, by modified RANO. Participants who had not progressed or died at the time of the analysis were censored at the date of their latest tumor assessment or survival assessment. | Up to 6 months |
| Progression-free Survival at 12 Months (PFS-12) | PFS-12 was defined as the time from the date of the first injection of SL-701 to the date of disease progression or death from any cause, whichever occurred first, by modified RANO. Participants who had not progressed or died at the time of the analysis were censored at the date of their latest tumor assessment. | Up to 12 months |
| Progression-free Survival (PFS) | PFS was defined as the time from the date of the first injection of SL-701 to the date of disease progression or death from any cause, whichever occurred first, by modified RANO. Participants who had not progressed or died at the time of the analysis were censored at the date of their latest tumor assessment. | 3 years |
| Overall Survival (OS) | OS was the time from the date of the first SL-701 injection to the date of death from any cause. If a participant did not die during the study, the participant's overall survival time was censored at the date at which the participant was last known to be alive. | 3 years |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Center for Neurosciences | Tucson | Arizona | 85718 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| Piedmont Cancer Institute | Atlanta | Georgia | 30309 | United States |
| Northwestern University | Chicago | Illinois | 60208 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Columbia University Medical Center | New York | New York | 10027 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15260 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Baylor Charles A Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| FG001 | SL-701 + Poly-ICLC + Bevacizumab | SL-701 emulsion and the adjuvant polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose (poly-ICLC) were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an intramuscular (IM) injection in the same extremity (within 3 centimeters [cm] whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered intravenously (IV) at a dose of 10 milligrams/kilogram (mg/kg). Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
| Received At Least 1 Dose of Study Drug | Intent-to-Treat Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SL-701 + GM-CSF + Imiquimod | Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream. A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site. In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later. |
| BG001 | SL-701 + Poly-ICLC + Bevacizumab | SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701 and with the last non-missing assessment taken prior to administration of the first SL-701 injection. | Mean | Standard Deviation | kilogram/meter squared |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Regimen-limiting Toxicity (RLT) | RLT included any events that occurred anytime through the first 12 doses of study treatment that were considered possibly, probably, or definitely related to investigational therapy and ranged from Grade ≥3 bronchospasm or Grade 2 bronchospasm that did not resolve within 24 hours despite appropriate medical treatment to cerebral edema associated with severe clinical manifestations (Grade 4) that were considered related to study therapy by the investigator. | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. | Posted | Count of Participants | Participants | Approximately 24 weeks |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Sudden or Unexpected Death Related to SL-701 or SL-701 in Combination With Bevacizumab | A safety review occurred following each sudden or unexpected death that was not considered by the investigator to be a disease-related mortality and was considered to be related to SL-701. | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. | Posted | Count of Participants | Participants | Day 1 through Month 12 |
| |||||||||||||||||||||||||||||||
| Primary | Overall Survival at 12 Months (OS-12) | OS-12 was defined as the number of participants surviving at 12 months after the first injection of SL-701 and was calculated using the Clopper-Pearson Method. | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. | Posted | Count of Participants | Participants | Up to 12 months |
| |||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR was the percentage of participants who had at least 1 overall tumor response of complete response (CR) or partial response (PR) documented on 2 consecutive magnetic resonance images (MRIs) ≥4 weeks apart by modified response assessment in neuro-oncology (RANO) criteria. | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR was the percentage of participants whose best response was either CR, PR, or stable disease (SD) documented on 2 consecutive MRIs ≥4 weeks apart by modified RANO criteria. | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | DoR was defined as the time from the date measurement criteria were first met for objective response (either CR or PR) until the first date that the criteria for progressive disease (PD) was met, or death due to any cause, whichever occurred first, by modified RANO. If a participant did not progress or die after a response of CR or PR, then the participant's DoR was censored at the date of the participant's last tumor assessment. Only participants who attained a confirmed response of either CR or PR were included in the estimation of DoR (calculated using the Kaplan-Meier method). | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Median | 90% Confidence Interval | month | 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Disease Control (DDC) | DDC was defined as the time from the date measurement criteria were first met for objective response (either CR, PR, or SD) until the first date that the criteria for PD were met, or death due to any cause, whichever occurs first, by modified RANO. If a participant did not progress or die after a response of CR, PR or SD, then the participant's DDC was censored at the date of the participant's last tumor assessment. Only participants who attained a confirmed response of either CR, PR or SD were included in the estimation of DDC. | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | month | 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival at 6 Months (PFS-6) | PFS-6 was defined as the time from the date of the first injection of SL-701 to the date of disease progression or death from any cause, whichever occurred first, by modified RANO. Participants who had not progressed or died at the time of the analysis were censored at the date of their latest tumor assessment or survival assessment. | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. | Posted | Median | 95% Confidence Interval | month | Up to 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival at 12 Months (PFS-12) | PFS-12 was defined as the time from the date of the first injection of SL-701 to the date of disease progression or death from any cause, whichever occurred first, by modified RANO. Participants who had not progressed or died at the time of the analysis were censored at the date of their latest tumor assessment. | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. | Posted | Median | 95% Confidence Interval | month | Up to 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from the date of the first injection of SL-701 to the date of disease progression or death from any cause, whichever occurred first, by modified RANO. Participants who had not progressed or died at the time of the analysis were censored at the date of their latest tumor assessment. | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. | Posted | Median | 95% Confidence Interval | month | 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was the time from the date of the first SL-701 injection to the date of death from any cause. If a participant did not die during the study, the participant's overall survival time was censored at the date at which the participant was last known to be alive. | Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701. | Posted | Median | 95% Confidence Interval | month | 3 years |
|
All-Cause Mortality: up to 3 years; Serious and Other Adverse Events: up to Month 12; Survival (PFS, OS), ORR, CR, PR, DDC, and DoR: up to 3 years.
Reported safety data based upon the Intent-to-Treat Population: all enrolled participants who received at least 1 dose of SL-701.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SL-701 + GM-CSF + Imiquimod | Participants received SL-701 with the vaccine adjuvants GM-CSF injection and imiquimod topical cream. A complete dose of study drug consisted of the administration of a sequence of 3 agents, SL-701 emulsion SC injection, GM-CSF SC injection, and imiquimod topical cream, within a 5-minute time frame. Topical application of imiquimod cream at the injection site was repeated at 24 h after each SL-701 emulsion injection. For each participant, SL-701 emulsion (SL-701 in Montanide) was administered by SC injection beginning on Day 1 with imiquimod topical cream 5% applied immediately (within 5 minutes after SL-701 emulsion injection) to the SL-701 emulsion injection site. In addition to the SL-701 emulsion injection, the participant received a SC injection of GM-CSF 150 μg close to the injection site of SL-701 emulsion (immediately following the SL-701 emulsion injection, before the application of topical imiquimod). An additional dose of imiquimod cream was applied at the same site by the participant 24 h later. | 38 | 46 | 14 | 46 | 42 | 46 |
| EG001 | SL-701 + Poly-ICLC + Bevacizumab | SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. | 16 | 28 | 9 | 28 | 28 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Performance status decreased | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peritumoural oedema | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Focal dyscognitive seizures | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Partial seizures with secondary generalisation | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vasogenic cerebral oedema | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abulia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Conjunctival irritation | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mydriasis | Eye disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Loose tooth | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Eye contusion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Pseudomeningocele | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Drug level decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 17.0 | Systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Posture abnormal | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Peritumoural oedema | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Apraxia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Clumsiness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Fine motor delay | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hemianopia homonymous | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertonia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Muscular weakness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Frustration tolerance decreased | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyposomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment | This adverse event affected only male participants. |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysaesthesia pharynx | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Induration | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development & Medical Affairs - Solid Tumors | Stemline Therapeutics, Inc. | 1-973-775-2845 | clinicaltrials@menarinistemline.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2017 | Oct 14, 2024 | SAP_003.pdf |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C019531 | poly ICLC |
| D011107 | Polylysine |
| D002266 | Carboxymethylcellulose Sodium |
| D000068258 | Bevacizumab |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D008239 | Lysine |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D010455 | Peptides |
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D001685 | Biological Factors |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
|
|
|
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
|
|
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
|
|
| SL-701 + Poly-ICLC + Bevacizumab |
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
|
|
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC.
SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
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| OG001 | SL-701 + Poly-ICLC + Bevacizumab | SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
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| OG001 | SL-701 + Poly-ICLC + Bevacizumab | SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
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| OG001 |
| SL-701 + Poly-ICLC + Bevacizumab |
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
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| SL-701 + Poly-ICLC + Bevacizumab |
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
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| SL-701 + Poly-ICLC + Bevacizumab |
SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
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SL-701 emulsion and the adjuvant poly-ICLC were administered twice weekly for the initial 2 weeks, every 7 days during the subsequent 3 doses, and subsequently every 14 days for the subsequent 9 doses (16 doses total) through Week 22, and every 4 weeks thereafter. Bevacizumab was administered every 2 weeks, after the administration of SL-701/poly-ICLC. SL-701: Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC was administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated). Bevacizumab: Following the administration of SL-701 and poly-ICLC, bevacizumab was administered IV at a dose of 10 mg/kg. Bevacizumab infusions occurred over 30, 60 or 90 minutes in accordance with institutional practices and guidelines. |
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